Clinical trial · Interventional
Carbon-Fibre Accessory (CARA) for Supine Breast Positioning to Reduce Toxicity in Whole Breast Radiotherapy
Multicentre Randomized Controlled Trial Of A Carbon-Fibre Adjustable Reusable Accessory (CARA) For Supine Breast Positioning To Reduce Toxicity In Whole Breast Adjuvant Radiotherapy
NCT04257396CI-TRIAL-00063408unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This trial is designed to assess the efficacy of a novel carbon-fibre adjustable reusable accessory (CARA) for breast support to reduce skin toxicity and unwanted normal tissue dose in comparison to the current clinical standard for supine breast support during whole breast RT.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adjuvant Radiotherapy for Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carbon-Fibre Adjustable Reuseable Accessory (CARA) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1 CARA Positioning
- description
- Arm 1 patients will receive CARA breast support. The known benefits to using CARA for breast positioning are reduction in IMF skin folds during treatment, reduction in breast separation, and reduction in V50% body, V105% body and lung V20 Gy in treatment planning. No known risks to using CARA have been identified.
- interventionNames
- Device: Carbon-Fibre Adjustable Reuseable Accessory (CARA)
- type
- NO_INTERVENTION
- label
- Arm 2 Standard of Care
- description
- Arm 2 patients will not receive CARA breast support. Patients in arm 2 may be treated with no breast support, a small foam wedge, a thermoplastic shell or alternate supine breast support method according to the current standard of care at the treating centre. These methods have entered RT clinical practice over decades of practice without published evidence of impact on rates of MD. Published rates of MD for the control arm thus pertain to a cross section of these methods. The control arm of this study will look at all of these methods combined. There may be centre specific preference for the control method and stratification by centre will be done.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 or older. * Able to provide informed consent * ECOG performance status 0 - 2 * Stage 0-3 invasive breast cancer or DCIS scheduled to received adjuvant radiotherapy to the whole breast * Any infra-mammary skin fold of \>= 0.5 cm in the supine treatment position and/or palpable lateral breast tissue falling posterior to the mid-axilla line while in supine or treatment position. Exclusion Criteria: * Inability to give informed consent or comply with experimental arm of trial * Previous RT to either breast or to the chest * Planned boost to infra mammary area * Use of Mepitel while on treatment * Failure to heal surgical wound or significant post-operative wound infection * Presence of significant connective tissue disease (e.g. systemic sclerosis, SLE) * Known radiation hypersensitivity phenotype (e.g. ataxia telangiectasia etc.) * Breast reconstruction * Planned partial breast irradiation, unless the treated area includes the infra-mammary fold
References
Publications (2)
- DERIVEDMalhotra A, Chan EK, Nichol A, Duzenli C. Spatial dose-distribution-based risk mapping to predict moist desquamation in breast radiotherapy. Phys Med Biol. 2025 May 27;70(11). doi: 10.1088/1361-6560/add985. PMID 40373801
- DERIVEDDuzenli C, Chan EK, Bergman AM, Grahame S, Singer J, Burns L, Olson RA. A novel carbon-fibre adjustable reusable accessory (CARA) for supine breast positioning to reduce toxicity in breast adjuvant radiotherapy: a study protocol for a multicentre phase III randomized controlled trial. BMC Cancer. 2022 Jun 20;22(1):673. doi: 10.1186/s12885-022-09759-y. PMID 35725457